Is Nonconsensual Tapering of High-Dose Opioid Therapy Justifiable? | Journal of Ethics | American Medical Association – by Travis N. Rieder, PhD – Aug 2020
This case considers a so-called legacy patient, one whose behaviors and symptoms express a legacy of past, aggressive opioid prescribing by a clinician.
Some prescribers might feel pressured to taper doses of opioids for such patients, but this article argues that nonconsensual dose reductions for stable opioid therapy patients is impermissible because it both puts a patient at risk and wrongs an individual in a misdirected attempt to ameliorate a systemic wrong.
Although perhaps surprising, this argument is supported by current evidence and recommendations for patient-centered pain care.
Then the article presents a case of a doctor, Dr. G., and a new long term opioid therapy patient, Mr. T, who has been taking 170MME opioids for some time.
Dr G suspects that the opioid therapy is primarily treating the physical dependence caused by the medication rather than the original pain.
This is what so many are saying: we only need opioids because we’ve become dependent and want to avoid withdrawals. When you’re an addiction specialist, all drug use looks like addiction, and any other reasons for taking a drug are discounted.
Based on recent guidelines, she also doesn’t think chronic opioid therapy was likely a good strategy for Mr T. She wonders whether to say this explicitly to Mr T and what to do next.
Yet this is a new doctor seeing this patient for the first time. How can she be so sure when she doesn’t even know the patient yet?
She’s apparently more concerned with following guidelines than treating her patient’s pain.
Guidelines like the one published by the Centers for Disease Control and Prevention (CDC) urge caution when initiating or escalating opioid prescriptions but leave unclear how such reductions are to be achieved.
The CDC guideline, however, has been widely misinterpreted as a mandate to deprescribe for existing patients—in particular, for legacy patients, so-called because their long-term use of often high-dose opioid therapy is a legacy of past, more aggressive prescribing practices.
Although some patients likely achieved this status due to their physicians failing to respect prescribing norms, many did not; long-term opioid therapy was simply seen as acceptable—sometimes even obligatory—during the late 1990s and early 2000s when pain was taken to be the “fifth vital sign” and opioids were sold to clinicians by pharmaceutical companies as safe and effective.
To me, it’s amazing how quickly the tide changed in just a decade from practically requiring the use of opioids in the early 2000s to opioid prohibition starting around 2010 and culminating in the 2016 CDC “guideline”.
Morally Relevant Features of Legacy Cases
Physicians in Dr G’s position might believe that the only ethically relevant question of the case is whether chronic opioid therapy is evidence-based practice.
Physicians like Dr G presumably believe that high-dose opioid therapy carries significant risks and thus that reducing or eliminating opioid use is indicated.
Initiation vs continuation.
The most important lesson for responsible opioid prescribing in cases like Mr T’s is that the presumption of a duty to taper as following from evidence-based medicine fails to acknowledge the difference between initiating patients on opioid therapy and continuing patients on opioid therapy.
This distinction is morally relevant for at least 2 reasons:
- first, because long-term opioid therapy patients can have profound physical dependence; and
- second, because what patients are entitled to can be affected by how they have been treated by the health care system in the past.
I’ll address each of these points briefly in turn.
The fact of physical dependence changes the risk-benefit profile of opioid therapy.
Mr T fears the withdrawal symptoms that come with discontinuing opioids, and this fear is a perfectly reasonable one: withdrawal can be far more than unpleasant or painful; it can be an absolute nightmare.
And because a patient who has been on chronic opioid therapy might know the symptoms of withdrawal well, the prospect of withdrawal itself can cause significant anxiety.
Indeed, withdrawal can be so devastating that patients who have their opioid therapy discontinued abruptly or are tapered too quickly have been reported to commit suicide.
Dr G likely believes that she can mitigate some of this suffering with a careful taper, but she cannot promise that tapering will be symptom free, or even that it won’t be miserable.
What little data we have about tapering in the most ideal circumstances do not provide much reason for optimism.
In other words, withdrawal is a hell that can last for weeks and months.
In one study, practiced experts attempted to carefully taper patients to below 90 MME or to transition those unable to taper onto buprenorphine. Despite the resources of a specialty clinic conducting slow, careful tapers, more than a third of the patients dropped out of the study; among those who successfully completed the taper, more than half reported increased pain.
So why are there so many media articles insisting that patients feel fine or even better after they are tapered?
In a separate study under essentially ideal conditions, in which patients volunteered for tapering interventions and investigators were national experts on the topic, results were heterogenous. Many patients were able to achieve moderate dose reductions, but others required increased doses.
Some experienced decreases in pain while others experienced increases in pain.
Again, this is never mentioned in most articles or studies. Everything I’ve read until now always claims that patients did not experience increases in pain, but here we get a more realistic look.
Slow, careful tapers, even for patients with access to far more professional expertise and resources than average patients, do not necessarily make patients more comfortable.
Indeed, even ideal tapering regimens can lead to an increase in pain, with no certainty that patients will be able to eventually complete the taper.
So true! This has certainly never been publicized and now I wonder where and how all those studies claim that pain isn’t worse after a taper.
Additionally, legacy patients are owed a certain amount of deference in choosing their treatment as a result of the situation in which the medical community has placed them.
High-dose legacy patients are different, however, because they’ve suffered iatrogenic harm from poor prescribing and poor medical management.
I’m angry that all high-dose patients are assumed to have received “poor medical management”, without considering their pain at all. No one wants to admit that opioids are working well for many of these patients.
If Dr G is correct that chronic opioid therapy isn’t good for Mr T…
I’m sick and tired of this nonsensical refrain, “opioids aren’t good for you”. It’s vague and meaningless, not even a medical concept, just an assumption without any basis in the particulars.
…then Mr T has already been wronged by being given an inappropriate treatment—perhaps by an unskilled prescriber or perhaps simply because norms concerning prescribing have changed. Now, he’s being pushed or required to go through withdrawal in the hope—but with no guarantee—that he won’t be in worse pain at the end of the whole ordeal
It might well be the case that there is something clinically and ethically wrong about continuing to prescribe high-dose opioids for some patients’ chronic, noncancer pain. But there is also something clinically and ethically wrong about forcing patients to endure exacerbated, protracted iatrogenic suffering.
physical dependence changes the risk-benefit profile of opioid prescribing due to the threat of withdrawal if the prescription is discontinued; and the patient, having already suffered an iatrogenic harm, should be given a voice in determining how best to mitigate that harm. These considerations suggest that there are reasons to continue a prescription even when initiating opioid therapy wasn’t appropriate.
Prescribing for Legacy Patients Is Not Always “Misprescribing”
Finally, the truth comes out.
dependence is characterized by withdrawal symptoms when a medication is abruptly discontinued.Dependence does not, by itself, entail addiction.
there is no clear ethical or legal requirement to discontinue prescribing for a patient physically dependent on opioids. Indeed, there could not be, since dependence forms as a matter of course for many medications, including opioids, benzodiazepines, and selective serotonin reuptake inhibitors.
So, how should physicians decide whether a given instance of prescribing constitutes a case of misprescribing? Kelly Dineen has shown that there is virtually no concrete guidance on this topic. In the absence of concrete guidance, physicians must ask in each case whether the benefits of opioid therapy outweigh the risks.
Pity the poor physicians, who must actually consider each patient as a unique individual.
Accordingly, physicians must consider in each case not only the risks of chronic opioid therapy but also the risks of deprescribing.
At least there’s some mention of the downsides/harms of restricting opioids that have been effective.
Forcibly tapering a patient, even when that patient does not suffer from addiction, can expose him to some harms of addiction. Withdrawal symptoms and pain are not only harms in themselves but also can destabilize a previously stable patient.
Forcibly tapering otherwise stable patients off high-dose, chronic opioid therapy reveals that this practice might have an effect that is the opposite of what public health is calling for:
it may be a harm expanding intervention, exposing those who have long received opioid medications variously to worsened pain, withdrawal, social instability amidst untreated dependence, or loss of medical care relationships.
When a patient is taking medicine to alleviate a symptom, whether it be high blood pressure, high blood sugar, or pain, the clinical reality is that taking that medicine away will lead to a resurgence of the symptom; that’s why these medications need to be taken for the rest of life.
This is so simple, straightforward, and logical that it seems crazy to claim that opioid reduction doesn’t lead to more pain, but that’s the claim in numerous heavily biased “studies”.
Taking such risks into account, continuing to prescribe high-dose opioid therapy for a legacy patient does not clearly constitute ethical or legal misprescribing.
Just try explaining that to the DEA. They don’t look at the patient’s condition or their history, just the milligrams of opioids prescribed and then go raid the highest prescribers in their “war on drugs”.
What Should a Physician Do?
The view that it is ethically impermissible to nonconsensually taper stable legacy patients, even when not tapering means prescribing some form of opioid therapy indefinitely, might surprise some.
But this view accords with recommendations offered in the US Department of Health and Human Services’ 2019 Guide for Clinicians on the Appropriate Dosage Reduction or Discontinuation of Long-Term Opioid Analgesics, which advises clinicians not to taper patients prior to their consent to a plan.